Johnson & Johnson recalled 12 million bottles of over-the-counter Mylanta and nearly 85,000 bottles of its AlternaGel liquid antacid in the U.S. and Puerto Rico Wednesday, bringing the pharmaceutical giant’s total recalls for the year to more than 200 million bottles of products, Reuters reports.
The company said in a news release that an internal review found that the packages for the antacid products did not note the presence of small amounts of alcohol from flavoring agents. On its website, Johnson & Johnson said “It is unlikely that use of these products will cause either alcohol absorption or alcohol sensitivity adverse events.”
Because of the recall, retailers must pull the products from store shelves, but consumers may continue to use the medicines they have already purchased. According to the company, they contain less than 1 percent alcohol.
The antacids are manufactured as part of a joint venture with the pharmaceutical company Merck & Co. and were produced in a plant in Lancaster, Pa. Earlier this year, a Johnson & Johnson plant in Fort Washington, Pa. was shut down because of quality control lapses that led to huge recalls of some of Johnson & Johnson’s most well-known brands, including Tylenol and Motrin.
The most recent recall comes only a week after the company recalled 9 million bottles of Tylenol because product packaging did not note the presence of alcohol. The products were made by a third-party manufacturer.
The recalls, by removing products from store shelves, have cut into Johnson & Johnson’s revenues recently. In the third quarter of this year, sales of consumer products dropped 25 percent.
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Johnson & Johnson / McNeill Consumer Healthcare is a prime example of corporate corruption, dishonesty and malfeasance. They don’t care one bit about how many people they harm. What may be even worse is the fact that the main media outlets are not reporting the WHOLE story.
A TIMELINE OF THE MCNEIL CONSUMER HEALTHCARE / JOHNSON & JOHNSON RECALLS:
2008: The so-called “phantom recall” took place, in which Johnson & Johnson allegedly hired contractors to pose as customers and buy a certain type of adult Motrin in order to remove the product from store shelves.
November 2009: McNeil recalled five lots of Tylenol Arthritis Pain Caplet 100 count bottles because of an unusual smell or taste. Consumers reported nausea and related symptoms.
December 2009: McNeil expanded the November recall to include all lots of Tylenol Arthritis Pain 100 count.
January 15, 2010: Johnson & Johnson issued a massive recall of over-the-counter drugs because of a moldy smell that has made people sick. The company determined that the odor was caused by the presence of a chemical called 2,4,6-tribromoanisole (TBA).
The FDA said McNeil knew of the problem in early 2008 but made only a limited investigation. Federal regulators criticized the company, saying it didn’t respond to the complaints quickly enough, wasn’t thorough in how it handled the problem and didn’t inform the Food and Drug Administration (FDA) quickly.
The recall includes, but is not limited to:
• Regular and extra-strength Tylenol
• Children’s Tylenol
• Tylenol Children’s Meltaways
• Tylenol 8 Hour
• Tylenol Arthritis
• Tylenol PM
• Tylenol Extra Strength
• Children’s Motrin
• Motrin IB
• Benadryl
• Rolaids Antacid
• Simply Sleep products
• St. Joseph’s aspirin
The FDA said about 70 people have been either sickened by the odor — including nausea, stomach pain, vomiting and diarrhea — or noticed it.
March 31, 2010 – McNeil recalls Zyrtec Itchy Eye Drops
April 30, 2010: McNeil announced that more than 40 types of children’s and infants’ products were voluntarily recalled. Quality issues included the possibility of the medication containing too much of the active ingredient, containing substandard inactive ingredients, or containing tiny particles. The recall included more than 135 million bottles of children’s medication.
May 5, 2010: Additional recalls: Tylenol, Motrin, Benadryl and ZYRTEC. The FDA found “serious” problems at the McNeil Consumer Healthcare plant. Raw materials were found to be contaminated with bacteria, but they were used anyway, the agency found. Quality control was lacking. And the company didn’t investigate potential manufacturing mess-ups, even after receiving consumer complaints about medicines contaminated with black particles, the report notes. “The findings are serious,” FDA official Deborah Autor tells the Washington Post. “Consumers should not use these products.”
May 6, 2010 – Philadelphia Public Health Examiner: The FDA has charged that McNeil knew the raw material had known contamination with gram negative organisms [bacteria] yet approved it for use to manufacture several lots of Children’s and Infant’s Tylenol drug products.. . . The FDA also slammed McNeil for its delayed response in handling the presence of a known contaminant in another one of its plants. The products recalled earlier this year were not children’s products. The earlier recall was for Rolaids and Tylenol extra Strength and a third Tylenol product. The complaints that led to these recalls did include three adverse events.
May 6, 2010 – CNNMoney.com — The FDA confirmed that the bacteria found at the Johnson & Johnson plant that produced the recalled children’s medicines was Burkholderia cepacia.
May 28, 2010: Blacksmith Brands, after conferring with the FDA, initiated a voluntary recall of four PediaCare children’s cough and cold products manufactured at the same McNeil Consumer Healthcare plant that was recently shut down because of poor quality manufacturing. Products included in the recall are:
• PediaCare Multi-Symptom Cold
• PediaCare Long Acting Cough
• PediaCare Decongestant
• PediaCare Allergy and Cold
June 15, 2010: McNeil expanded its Jan. 15, 2010, recall to include five more lots of Benadryl and Tylenol that were “inadvertently omitted from the initial recall action.” Congress announced it would investigate.
July 8, 2010: McNeil Consumer Healthcare is now recalling 21 more lots of over-the-counter medicines sold in the U.S., Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago and Jamaica, including:
• Benadryl Allergy Ultratab Tablets
• Children’s Tylenol Meltaways Bubblegum
• Motrin IB Caplets and Tablets
• Tylenol Extra Strength, EZ Tablets, Cool Caplets, Day & Night
• Tylenol Rapid Release GelCaps, Tylenol 8 Hr, Tylenol Arthritis, Tylenol PM
• Tylenol PM Caplets, Geltabs, and Rapid Release Gelcaps
• Tylenol, Motrin, Zyrtec, Benadryl
Also, five complaints filed in the U.S. District Court for Northern Illinois against McNeil are seeking class-action status. Consumers accused McNeil of fraud and racketeering for not recalling all of its children’s products and for not adequately reimbursing consumers for their out-of-pocket expenses. . The buyers of those recalled meds are demanding cash refunds–rather than coupons for replacement products–in five suits.
July 16, 2010 – Jere Beasley Report: Rep. Towns, chairman of the House Committee on Oversight and Government Reform, says Johnson & Johnson has used delaying tactics in its dealings with the committee and in some instances had provided misinformation. . . The FDA has referred the McNeil case to its office of criminal investigation. http://www.jerebeasleyreport.com/2010/07/drug-maker-fails-to cooperate/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+JereBeasleyReport+(Jere+Beasley+Report